Surgical access system including surgical portal apparatus and adhesive patch

ABSTRACT

The present disclosure relates to surgical access systems and methods of using the same to access a surgical site during a surgical procedure. The surgical access system includes a portal member and a patch. The portal member includes at least one longitudinal port for passage of a surgical object. The portal member is formed from a compressible material and is adapted to transition from a first expanded condition to a second compressed condition such that an outer surface of the portal member is adapted for a substantial sealing relation with an opening in tissue upon insertion of the portal member therethrough. The patch includes a non-porous substrate having a tissue facing surface including an adhesive for positioning over the opening in the tissue and sealing a surface thereof. The patch is adapted for sealed reception of the portal member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a National Stage Application of PCT/US12/48913 under35 USC §371 (a), which claims priority of U.S. Provisional PatentApplication Ser. No. 61/522,790 filed Aug. 12, 2011, the disclosures ofeach of the above-identified applications are hereby incorporated byreference in their entirety.

BACKGROUND

1. Technical Field

The present disclosure relates generally to a surgical access system foruse in a surgical procedure, and more particularly, to a surgical accesssystem including a surgical portal apparatus and an adhesive patch forforming a fluid tight seal with both tissue and one or more surgicalobjects positioned therethrough.

2. Background of Related Art

Today, many surgical procedures are performed through small incisions inthe skin, as compared to the larger incisions typically required intraditional procedures, in an effort to reduce both trauma to thepatient and recovery time. Generally, such procedures are referred to as“endoscopic”, unless performed on the patient's abdomen, in which casethe procedure is referred to as “laparoscopic”. Throughout the presentdisclosure, the term “minimally invasive” should be understood toencompass both endoscopic and laparoscopic procedures.

During a typical minimally invasive procedure, surgical objects, such assurgical access devices, e.g., trocar and cannula assemblies, orendoscopes, are inserted into the patient's body through the incision intissue. In general, prior to the introduction of the surgical objectinto the patient's body, insufflation gases are used to enlarge the areasurrounding the target surgical site to create a larger, more accessiblework area. Accordingly, the maintenance of a substantially fluid-tightseal is desirable so as to prevent the escape of the insufflation gasesand the deflation or collapse of the enlarged surgical site.

To this end, various surgical ports with valves and seals are usedduring the course of minimally invasive procedures and are widely knownin the art. The small incisions, however, are typically enlarged forspecimen removal from the patient's body. The enlarged opening prohibitscontinued use of the surgical port therethrough as the opening hasbecome too large to maintain a fluid-tight seal with the surgical port.Additional incisions may be required for continued access of thesurgical site with a surgical port.

A continuing need exists for a surgical access system that canfacilitate the accessibility of an underlying tissue site with relativeease and with minor inconvenience for a clinician. It would beadvantageous to provide a surgical access system that would allow forcontinued use, or re-use, of a surgical port after an incision isenlarged while maintaining a fluid tight seal with the enlargedincision.

SUMMARY

The present disclosure relates to surgical access systems and methods ofusing the same during a surgical procedure. The surgical access systemincludes a portal member and a patch. The portal member includes atleast one longitudinal port for passage of a surgical object. The portalmember is formed from a compressible material and is adapted totransition from a first expanded condition to a second compressedcondition such that an outer surface is adapted for a substantialsealing relation with an opening in tissue upon insertion of the portalmember therethrough. The patch includes a non-porous substrate having atissue facing surface including an adhesive for positioning over theopening in the tissue and sealing a surface thereof. The patch isadapted for sealed reception of the portal member.

In accordance with one embodiment of the present disclosure, to access asurgical site, a patch including a non-porous substrate having a tissuefacing surface including an adhesive is placed over an opening in tissueand seals a surface thereof. A portal member is then positioned throughan aperture in the patch. The portal member includes at least onelongitudinal port for passage of a surgical object. The portal member isformed from a compressible material and is adapted to transition from afirst expanded condition to a second compressed condition such that anouter surface is adapted for a substantial sealing relation with theaperture of the patch and the opening in the tissue upon insertion ofthe portal member therethrough.

In accordance with another embodiment of the present disclosure, toaccess a surgical site, a portal member including at least onelongitudinal port for passage of a surgical object is placed in anopening in tissue. The portal is formed from a compressible material andis adapted to transition from a first expanded condition to a secondcompressed condition such that an outer surface is adapted for asubstantial sealing relation with the opening in the tissue uponinsertion of the portal member therethrough. Surgical objects are placedthrough the at least one longitudinal port. The portal member is removedfrom the opening in the tissue and the opening of the tissue isenlarged. A patch including a non-porous substrate having a tissuefacing surface including an adhesive is positioned over the enlargedopening in the tissue and seals a surface thereof. The portal member maythen be placed through the patch in sealed relation therewith.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present disclosure are described hereinbelowwith reference to the drawings, wherein:

FIG. 1 is a front perspective view of a surgical access system includinga portal member and a patch positioned relative to tissue in accordancewith the principles of the present disclosure;

FIG. 2 is a cross-sectional view of the portal member of FIG. 1 takenalong line 2-2 of FIG. 1 illustrating a longitudinally extending port ofthe seal anchor member;

FIG. 3A is a top view of a patch in accordance with another embodimentof the present disclosure;

FIG. 3B is a top view of a patch in accordance with yet anotherembodiment of the present disclosure;

FIG. 4A is a cross-sectional view of the patch of FIG. 3A in accordancewith one embodiment of the present disclosure;

FIG. 4B is a top view of a patch in accordance with another embodimentof the present disclosure; and

FIG. 4C is a top view of a patch in accordance with yet anotherembodiment of the present disclosure.

DETAILED DESCRIPTION OF EMBODIMENTS

In accordance with the present disclosure, a surgical access system isutilized to access a surgical site. The surgical access system includesa surgical portal apparatus, e.g., a portal member, adapted forinsertion into an opening, e.g., an incision, in tissue to form afluid-tight seal with the tissue and an adhesive patch that creates anartificial surface or interface through which the portal member may beplaced.

Particular embodiments of the present disclosure will be describedherein with reference to the accompanying drawings. As shown in thedrawings and as described throughout the following description, and asis traditional when referring to relative positioning on an object, theterm “proximal” or “trailing” refers to the end of the apparatus that iscloser to a clinician and the term “distal” or “leading” refers to theend of the apparatus that is farther from a clinician. As used herein,the term “patient” should be understood as referring to a human subjector other animal, and the term “clinician” should be understood asreferring to a doctor, nurse, or other care provider and may includesupport personnel. In the following description, well-known functions orconstructions are not described in detail to avoid obscuring the presentdisclosure in unnecessary detail.

One type of minimal invasive surgery described herein is multipleinstrument access through a single surgical port. Multiple instrumentaccess through a single surgical port is a minimally invasive surgicalprocedure, which permits a clinician to operate through a single entrypoint, typically the patient's navel. The disclosed multiple instrumentaccess through a single surgical port procedure may involve insufflatingthe body cavity and positioning a portal member within, e.g., the navelof the patient. Examples of surgical instruments or objects which may beintroduced through the portal member include clip appliers, graspers,dissectors, retractors, staplers, forceps, laser probes, photographicdevices, trocars, cannulas, endoscopes, laparoscopes, arthroscopes,tubes, electrosurgical cutting, coagulating, and ablation devices, andother tools within the purview of those skilled in the art.

Referring now to the drawings, in which like reference numerals identifyidentical or substantially similar parts throughout the several views,FIG. 1 illustrates a surgical access assembly 100 including a portalmember 102 and a patch 104 that may be used in any endoscopic,laparoscopic, and/or open surgical procedure in accordance with theprinciples of the present disclosure. Portal member 102 includes anelongated body 110 defining a longitudinal axis “A” and includingtrailing (or proximal) and leading (or distal) ends 112 and 114,respectively. Portal member 102 includes at least one longitudinal port116, in embodiments, a plurality of longitudinal ports 116, extendingalong axis “A” between trailing and leading ends 112 and 114,respectively, and through the elongated body 110. At least one or moreports 116 are dimensioned to receive a surgical object, such as acannula 106 therethrough. Upon introduction through a respective port116, the inner surface portions 117 (FIG. 2) defining the port 116establish and maintain a substantially sealed relation about thesurgical object. Cannula 106 may be inserted through the at least onelongitudinal port 116 and provides a fluid-tight seal with the port 116.Cannula 106 provides an access port 107 including a valve (not shown)for passage of surgical instruments, e.g., endoscopic instruments,therethrough.

Trailing and leading ends 112 and 114 may define flange segments 118,which may be integrally formed with portal member 102. Trailing end 112of portal member 102 defines a first diameter D₁ and leading end 114defines a second diameter D₂. In embodiments, the respective first andsecond diameters D₁, D₂ of the trailing and leading ends 112 and 114 aresubstantially equivalent, as seen in FIG. 1. In other embodiments,diameters D₁, D₂ may be different. As depicted in FIG. 1, trailing andleading ends 112 and 114 define substantially planar surfaces. However,it is also contemplated that either or both of trailing and leading ends112 and 114, respectively, may define surfaces that are substantiallyarcuate to assist in the insertion of portal member 102 within a tissueopening 12 defined by tissue surfaces 14 and formed in tissue “T”, e.g.an incision.

Elongated body 110 defines a radial dimension “R” and extendslongitudinally between trailing and leading ends 112 and 114,respectively, to define an axial dimension or length “L”. The radialdimension “R” of elongated body 110 varies along the axial dimension, orlength, “L” thereof to aid in anchoring portal member 102 within tissue“T”. Other embodiments in which the radial dimension “R” remainssubstantially uniform along the axial dimension “L” thereof is alsowithin the scope of the present disclosure.

The radial dimension “R” of elongated body 110 may be appreciably lessthan the respective diameters D₁, D₂ of trailing and leading ends 112and 114 such that the portal member 102 defines an “hour-glass” shape orconfiguration to assist in anchoring portal member 102 within tissue“T”. However, in alternate embodiments, the radial dimension “R” ofelongated body 110 may be substantially equivalent to the respectivediameters D₁ and/or D₂ of trailing and leading ends 112 and 114. Incross section, elongated body 110 may exhibit any suitableconfiguration, e.g. substantially circular, oval, or oblong.

Portal member 102 may be made from a disposable, compressible, and/orflexible type material, such as, for example, a suitable foam or gelmaterial having sufficient compliance to deform and establish a sealabout one or more surgical objects, and also establish a sealingrelation with the tissue. The compressible material may be sufficientlycompliant to accommodate off axis motion of the surgical object. In oneembodiment, the material is a foam including a polyisoprene material. Inembodiments, the material may be fabricated from an elastomer such as asoft urethane gel, silicone gel, thermoplastic elastomer, or the like.

Portal member 102 is adapted for insertion within a tissue tract “T”,e.g., through the abdominal or peritoneal lining in connection with alaparoscopic surgical procedure. Portal member 102, however, is adaptedfor insertion within any opening in a patient's skin, e.g., an incisionor any naturally occurring orifice. The presently disclosed portalmember 102 and surgical access system 100 may be used with a surgicallycreated incision, a naturally occurring opening, or in non-laparoscopicprocedures.

When inserted within an opening 12 in tissue “T”, portal member 102 isadapted to establish a substantial seal within the opening 12, i.e.,with the tissue surfaces 14 defining the opening 12. Portal member 102is dimensioned to provide a fluid tight seal with an opening 12 of about2 mm to about 18 mm. In embodiments, portal member 102 is about 5 mm toabout 20 mm in diameter in its unbiased, expanded condition. Duringinsertion, portal member 102 may be compressed from its first, expandedcondition to a second, compressed condition to permit at least partialpassage through the opening 12 in tissue “T”. Once within the opening12, portal member 102 will return toward the first, expanded conditionwith the outer wall 120 of the portal member 102 establishing a sealwith the tissue “T” defining the opening 12.

Portal member 102 may include an insufflation conduit (not shown)mounted within one of ports 116 and connectable to a source ofinsufflation gases to permit passage of gases, e.g., CO₂, to maintainthe pneumoperitoneum. Other suitable portal members which may beutilized with the surgical access system 100 of the present disclosureincluding, for example, those disclosed in commonly assigned U.S. PatentApplication Pub. No. 2009/0093752, entitled “Seal Anchor for Use inSurgical Procedures”, the entire contents of which is herebyincorporated by reference herein.

Patch 104 includes a non-porous substrate 130 including a tissue facingsurface 132 including an adhesive 134 that is adapted to adhere totissue “T”. Non-porous substrate 130 of patch 104 may be a film, foam,mesh, fibrous sheet, or composite thereof adapted to adhere and sealtissue.

Non-porous substrate 130 is fabricated from suitable materials such thatthe patch 104 has sufficient tensile strength to support the portalmember 102 during use in a surgical procedure; is sufficiently inert toavoid foreign body reactions when retained on tissue “T” for longperiods of time; and is easily sterilized to prevent the introduction ofinfection when the patch 104 is placed against opening 112 of tissue“T”.

Examples of suitable materials include, for example, polyolefins such aspolyethylene (including ultra high molecular weight polyethylene) andpolypropylene including atactic, isotactic, syndiotactic, and blendsthereof; polyethylene glycols; polyethylene oxides; polyisobutylene andethylene-alpha olefin copolymers; fluorinated polyolefins such asfluoroethylenes, fluoropropylenes, fluoroPEGSs, andpolytetrafluoroethylene; polyamides such as nylon, Nylon 6, Nylon 6,6,Nylon 6,10, Nylon 11, Nylon 12, and polycaprolactam; polyamines;polyimines; polyesters such as polyethylene terephthalate, polyethylenenaphthalate, polytrimethylene terephthalate, and polybutyleneterephthalate; polyethers; polybutester; polytetramethylene etherglycol; 1,4-butanediol; polyurethanes; acrylic polymers; methacrylics;vinyl halide polymers such as polyvinyl chloride; polyvinyl alcohols;polyvinyl ethers such as polyvinyl methyl ether; polyvinylidene halidessuch as polyvinylidene fluoride and polyvinylidene chloride;polychlorofluoroethylene; polyacrylonitrile; polyaryletherketones;polyvinyl ketones; polyvinyl aromatics such as polystyrene; polyvinylesters such as polyvinyl acetate; etheylene-methyl methacrylatecopolymers; acrylonitrile-styrene copolymers; ABS resins; ethylene-vinylacetate copolymers; alkyd resins; polycarbonates; polyoxymethylenes;polyphosphazine; polyimides; epoxy resins; aramids; rayon;rayon-triacetate; spandex; silicones; and copolymers and combinationsthereof.

Patch 104 is dimensioned to surround opening 12 in tissue “T” such thatthe patch 104 adheres to the surrounding tissue “T” to create a sealaround opening 12. Accordingly, patch 104 may be any suitable shape orsize, such as rectangular as illustrated in FIG. 1, circular asillustrated in FIG. 3A, among other shapes within the purview of thoseskilled in the art. In embodiments, patch 104 may be cut to a desiredsize and shape. Patch 104 may also be substantially planar (FIG. 1) orconcave (FIG. 4A) to seal opening 12 of tissue “T”.

Adhesive 134 may be applied to a portion of the patch 104, such ascoated on the entire tissue facing surface 132 of patch 104 (FIG. 1), oraround a periphery thereof (FIG. 4A). It is envisioned that the adhesivemay be applied in a random or systematic pattern around the tissuefacing surface 132 of patch 104. In embodiments, adhesive 134 ispre-applied to patch 104, while in other embodiments, adhesive 134 maybe applied to patch 104 prior to application to tissue “T”.Additionally, or alternatively, the patch 104 may include mechanicalmeans for binding to tissue. In embodiments, the patch may includemechanical grips or hooks to achieve, or enhance, adhesivity to tissue.

The adhesive is a biocompatible material capable of effecting temporaryattachment between the patch and tissue. Adhesives which may be utilizedwith the surgical access system of the present disclosure include, butare not limited to, adhesive which cure upon tissue contact, which cureupon exposure to ultraviolet (UV) light, which are two-part systemswhich are kept isolated from one another and cure upon coming intocontact with one another, which are pressure sensitive, which are anycombinations thereof, or any other known suitable adhesive. Examples ofadhesives include, for example, silicones, acrylics, polyurethanes,polyesters, polyamides, and rubber-based adhesives. In embodiments, ahydrogel is utilized as an adhesive. Hydrogels are materials that absorbsolvents (such as water), undergo rapid swelling without discernibledissolution, and maintain three-dimensional networks capable ofreversible deformation. Hydrogels may also be utilized as a two-partadhesive system in which the hydrogel is a network of crosslinkedmolecules formed by reacting first and second hydrogel precursors. Thefirst and second hydrogel precursors include functional groups, e.g.,nucleophilic or electrophilic functional groups, which combine to form acrosslinked polymeric product as a result of electrophilic-nucleophilicreactions. Hydrogels include, for example, those using syntheticprecursors within the purview of those skilled in the art, such as thoseused in commercially available products such as FocalSeal® from Genzyme,Inc., Coseal® from Angiotech Pharmaceuticals, and DuraSeal® fromConfluent Surgical, Inc. Other examples of adhesives which can beemployed include protein derived, aldehyde-based adhesive materials, forexample, the commercially available albumin glutaraldehyde materialssold under the trade designation BioGlue™ by Cryolife, Inc., andcyanoacrylate-based materials sold under the trade designationsIndermil™ and Derma Bond™ by Tyco Healthcare Group, LP and EthiconEndosurgery, Inc., respectively.

The adhesive patch facilitates insertion of the portal member within atissue opening when the opening is an irregular shape or too large tosolely accommodate the portal member in sealing relation, e.g., in anincision larger than about 20 mm, for example, larger than about 25 mmto about 30 mm. As illustrated in FIG. 1, an aperture 136 (shown inphantom) may be cut by a clinician into patch 104 to a desired size andshape. Aperture 136 is cut into patch 104 by creating a slit in thenon-porous substrate 130 or cutting a desired shape corresponding to theshape of the portal member 102, for example.

Alternatively, the patch may include a pre-formed or pre-patternedaperture. In one embodiment, such as shown in FIG. 3A, patch 204includes a pre-formed aperture 236. The diameter of aperture 136, 236should be substantially equal or smaller than the diameter of elongatedbody 110 of portal member 102 such that a fluid-tight fit is formedbetween the portal member 102, patch 104, 204, and tissue “T”. Inanother embodiment, as illustrated in FIG. 3B, patch 204 may include oneor more pre-patterned apertures 236′, 236″, and 236′″ designated byperforation lines 237′, 237″, and 237′″, respectively, extending aroundthe perimeter of apertures 236′, 236″, and 236′″. The strength of thepatch 204 is reduced at each perforation line 237′, 237″, and 237′″ sothat the material within the perforation lines 237′, 237″, and/or 237′″may be pressed, torn, or otherwise removed to form the aperture 236′,236″, or 236′″. In this manner, the appropriate size of the aperture maybe selected at the time of use, corresponding to the size of the portalmember. In embodiments, the inner, first perforation line 237′ may beconfigured to tear when a relatively low force is applied to the patch204 in the vicinity of the perforation line 237′, while the secondperforation line 237″ may tear when a higher lever of force is appliedto the patch 204, and the third perforation line 237′″ may tear when aneven higher level of force is applied to the patch 204 to minimizeinadvertent separation at the perforation lines.

In embodiments, as illustrated in FIGS. 4A-4C, non-porous substrate 230of patch 204 may include a reinforcement member 238, 239, and 240,respectively, to provide the desired strength to the patch 104, toprevent the aperture 236 from expanding, and to support the portalmember 102 (FIG. 1) during use. Non-limiting examples of thereinforcement member includes meshes, monofilaments, multifilamentbraids, staple fibers, and combinations thereof. In embodiments, thereinforcement member 238 may be an additional woven or non-wovenstructure disposed within at least a portion, or entirely through, thenon-porous layer 230 as illustrated in FIG. 4A, or the reinforcementmember 239 may be positioned on a surface of the non-porous layer 230,as illustrated in FIG. 4B, to form a multi-layered structure. In someembodiments, patch 204 may be reinforced by stitching the periphery ofaperture 236 with a monofilament or multifilament thread 240, e.g., asuture, as illustrated in FIG. 4C.

In use, the operator of the surgical access system 100 will insert theportal member 102 into the opening 12 of tissue “T” such that portal 102is disposed within opening 12. Flanges 118 of the portal member 102 mayaid in anchoring the portal member 102 in tissue “T”. Surgicalinstruments, such as a cannula, may then be inserted into longitudinalport 116 of portal member 102 and procedures, e.g., minimally invasiveprocedures, may be performed. To remove or pass a specimen through thetissue “T” (e.g., the permanent removal of diseased internal anatomyand/or temporary removal of portions of the colon to be manipulatedoutside of the body before being returned to inside the body), theportal member 102 is removed and the opening 12 is enlarged to allow forpassage of the specimen therethrough. Thereafter, patch 104 may beapplied to the enlarged opening 12 and portal member 102 may be insertedtherethrough so that the procedure proceeds in a manner described abovewithout requiring multiple incisions for accessing the surgical site.

It should be understood that the surgical access system 100 may also beused where a relatively large opening exists that is too large toaccommodate a portal member.

Persons skilled in the art will understand that the devices and methodsspecifically described herein and illustrated in the accompanyingdrawings are non-limiting exemplary embodiments. It is envisioned thatthe elements and features illustrated or described in connection withone exemplary embodiment may be combined with the elements and featuresof another without departing from the scope of the present disclosure.As well, one skilled in the art will appreciate further features andadvantages of the system based on the above-described embodiments.Accordingly, the present disclosure is not to be limited by what hasbeen particularly shown and described, except as indicated by theappended claims.

What is claimed is:
 1. A surgical access system comprising: a portalmember including at least one longitudinal port for passage of asurgical object, the portal member comprising a compressible materialand being adapted to transition from a first expanded condition to asecond compressed condition such that an outer surface is adapted for asubstantial sealing relation with an opening in tissue upon insertion ofthe portal member therethrough; and a patch comprising a non-poroussubstrate including a tissue facing surface including an adhesive forpositioning over the opening in the tissue and sealing a surfacethereof, the patch defining an aperture dimensioned for sealed receptionof the portal member.
 2. The surgical access system of claim 1, whereinthe aperture is pre-formed in the patch.
 3. The surgical access systemof claim 1, wherein the aperture is created from a pattern on the patch.4. The surgical access system of claim 1, wherein the patch issubstantially planar.
 5. The surgical access system of claim 1, whereinthe patch is concave.
 6. The surgical access system of claim 1, whereinthe adhesive coats an entire portion of the tissue facing surface of thenon-porous substrate.
 7. The surgical access system of claim 1, whereinthe adhesive coats a peripheral portion of the tissue facing surface ofthe non-porous substrate.
 8. The surgical access system of claim 1,wherein the patch includes a reinforcement member.
 9. The surgicalaccess system of claim 8, wherein the reinforcement member is selectedfrom the group consisting of meshes, monofilaments, multifilamentbraids, staple fibers, and combinations thereof.
 10. The surgical accesssystem of claim 8, wherein the reinforcement member is disposed withinthe patch.
 11. The surgical access system of claim 8, wherein thereinforcement member is disposed on a surface of the patch.
 12. Thesurgical access system of claim 1, wherein the portal member definesleading and trailing ends, the at least one longitudinal port extendingbetween the leading and trailing ends and being adapted for reception ofan object whereby the compressible material defining the at least oneport is adapted to deform to establish a substantially sealed relationwith the surgical object.
 13. The surgical access system of claim 1,further comprising a cannula adapted for positioning through the atleast one longitudinal port for accessing a surgical site.
 14. A methodof accessing a surgical site comprising the steps of: placing a portalmember in an opening in tissue, the portal member including at least onelongitudinal port for passage of a surgical object, the portal membercomprising a compressible material and being adapted to transition froma first expanded condition to a second compressed condition such that anouter surface is adapted for a substantial sealing relation with theopening in the tissue upon insertion of the portal member therethrough;placing surgical objects through the at least one longitudinal port;removing the portal member from the opening in the tissue; enlarging theopening in the tissue; positioning a patch comprising a non-poroussubstrate including a tissue facing surface including an adhesive overthe enlarged opening in the tissue and sealing a surface thereof; andplacing the portal member through the patch in sealed relationtherewith.
 15. The method of claim 14, further comprising the step of:cutting the opening in the tissue prior to placing a portal membertherein.
 16. The method of claim 14, further comprising the step of:removing a specimen through the enlarged opening prior to positioningthe patch thereover.
 17. The method of claim 14, further comprising thestep of: providing an aperture in the patch that is dimensioned toreceive the portal member.
 18. The method of claim 14, furthercomprising the step of: applying the adhesive to the patch prior topositioning the patch over the enlarged opening in the tissue.